Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System of Patients Following Radioiodine Therapy for Thyroid Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Level of Radioactive Iodine in Tears
研究概览
简要总结
The purpose of this study is to explore whether administration of preservative free artificial tears will decrease the level of detectable radioiodine in the tears and nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and thus decrease the risk of developing radioactive iodine associated nasolacrimal duct obstruction.
详细描述
Primary Objective:
- To assess whether use of preservative free artificial tears following radioactive iodine administration will lower the level of radioactive iodine in the tears of patients treated with radioactive iodine for thyroid carcinoma.
Secondary Objective:
- To evaluate whether artificial tears would be an effective preventative intervention to decrease the risk of developing nasolacrimal duct stenosis, which has been associated with radioactive iodine administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radio-iodine therapy for thyroid cancer
- •Radioiodine therapy ≥100mCi
- •Patient wears soft contacts on both eyes
排除标准
- •Use of eye drops, other than artificial tears
- •History of periocular trauma with tear duct involvement/lacrimal gland trauma
- •History of lacrimal drainage disease: canaliculitis, dacryocystitis
- •Prior radiotherapy
- •Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
- •Medical conditions that predispose to NLD stenosis
- •Granulomatosis with polyangiitis
- •Chronic lymphocytic leukemia
研究组 & 干预措施
Preservative free artificial tears
Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours.
干预措施: Artificial Tears (Drug)
结局指标
主要结局
Change in Level of Radioactive Iodine in Tears
时间窗: Over a 4 day period
The radioactive iodine activity level in the tears will be measured, as collected via contact lenses. Each patient will have a control eye and an experimental eye that received artificial tears. The control eye has no intervention. The radioactive iodine activity level will be measured over four days, with Day 1 occurring on the Day of systemic radioactive iodine therapy. On each of the four days, the level of radioactive iodine will be compared between the control and experimental eyes to see if there is a statistical difference between the control and experimental eyes.
次要结局
未报告次要终点
研究者
Rachel Sobel
Principal Investigator
Vanderbilt-Ingram Cancer Center